MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD F&P SLEEPSTYLE AUTO CPAP; BZD

Model Number SPSAAA

Device Problems Disconnection (1171); Device Slipped (1584)

Patient Problem Pain (1994)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint f&p sleepstyle series cpap was recently received at fisher & paykel healthcare in (b)(4) for evaluation.We will provide a follow-up report upon completion of our investigation.

Event Description

A distributor in (b)(4) reported via a fisher & paykel healthcare field representative that upon removing the power cord from the back of the f&p sleepstyle auto cpap, the pins from the mains inlet socket came out.The power cord was still connected to the wall outlet, and the patient made contact with the pins leaving a mark on the palm of their hand.No further patient consequence was reported.

Event Description

A distributor in australia reported via a fisher & paykel healthcare field representative that upon removing the power cord from the back of the f&p sleepstyle auto cpap, the pins from the mains inlet socket came out.The power cord was still connected to the wall outlet, and the patient made contact with the pins leaving a mark on the palm of their hand.No further patient consequence was reported.

Manufacturer Narrative

Ps298616 method: the complaint f&p sleepstyle series cpap was received at fisher & paykel healthcare in new zealand and was visually inspected internally and externally.Results: visual inspection confirmed that one pin had detached from the mains inlet socket.Conclusion: the reported incident was traced to an issue in the assembly process of the supplied mains inlet connector component.The supplier of the component was notified and they have made changes to the assembly process.As part of our ongoing product improvement initiatives, we recently implemented a test which identifies and rejects any potentially faulty mains inlet sockets prior to assembly into the sleepstyle.The subject sleepstyle was manufactured prior to implementation of these measures.Our user instructions that accompany the f&p sleepstyle state the following: - do not use if the device, power cord or accessories are damaged, deformed, or cracked.- do not pull on the power cord as it may become damaged.- turn the device off at the power supply, then remove the power cord from the rear of the device.

• Brand Name: F&P SLEEPSTYLE AUTO CPAP
• Type of Device: BZD
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 8309454
• MDR Text Key: 137531584
• Report Number: 9611451-2019-00089
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 09420012442956
• UDI-Public: (01)09420012442956(10)2100582859(11)180913
• Combination Product (y/n): N
• PMA/PMN Number: K173193
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 01/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SPSAAA
• Device Catalogue Number: SPSAAA
• Device Lot Number: 2100582859
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2019
• Initial Date Manufacturer Received: 01/07/2019
• Initial Date FDA Received: 02/06/2019
• Supplement Dates Manufacturer Received: 06/18/2019
• Supplement Dates FDA Received: 07/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1